Tool for tricuspid regurgitation operation

ABSTRACT

The present invention relates to a device for transcatheter treatment for tricuspid regurgitation. The device for transcatheter treatment for tricuspid regurgitation, according to one preferred embodiment of the present invention, includes: the coronary sinus tube inserted into the coronary sinus; and the tricuspid valve tube traversing the tricuspid valve, wherein the coronary sinus tube and the tricuspid valve tube communicate with each other or are adjacent to each other within a range of predetermined length at an upper side and are separate from each other at a lower side, and a blocking member for blocking a space generated by incomplete closing of the tricuspid valve is provided at a lower part of the tricuspid valve tube or between the coronary sinus tube and the tricuspid valve tube.

TECHNICAL FIELD

The present invention relates to a device for transcatheter treatmentfor tricuspid regurgitation and, more particularly, to a device fortranscatheter treatment for tricuspid regurgitation, wherein the devicecan perform a catheter treatment for tricuspid regurgitation (TR) whichis a disease that the tricuspid valve (TV) located between the rightatrium and the right ventricle of the heart does not close completely,thereby causing the blood to flow backward in the heart.

BACKGROUND ART

The heart is divided into four chambers: two atria and two ventricles,which are connected to four blood vessels such as the main artery, themain vein, the pulmonary artery and the pulmonary vein, therebyfunctioning as a passage for blood delivery.

An interventricular septum in the center of the heart separates theheart into two sides: right atrium and right ventricle in one side, andleft atrium and left ventricle in the other side. The tricuspid valve islocated between the right atrium and the right ventricle, and the mitralvalve is located between the left atrium and the left ventricle.

The heart functions as a pump by repeating contraction and relaxation,to allow the blood to flow along the blood vessels. In the systole ofthe heart, as the blood in the heart flows forwardly to the bloodvessels, the blood in the right heart is delivered from the rightventricle to the pulmonary artery and the blood in the left heart isdelivered from the left ventricle to the main artery.

However, if a valve between an atrium and a ventricle does not properlyoperate, the blood of the ventricle flows backward in the systole of theheart, that is, moves toward the atrium. If the tricuspid valve betweenthe right atrium and the right ventricle does not properly operate, theblood of the right ventricle flows backward into the right atrium; thisis called “tricuspid regurgitation”, and if the mitral valve between theleft atrium and the left ventricle does not property operate, the bloodof the left ventricle flows backward into the left atrium. This iscalled “mitral regurgitation”.

In tricuspid regurgitation (TR), the blood is not delivered to thepulmonary artery when the heart contracts because the tricuspid valvedoes not properly operate, thus causing the blood to flow backward intothe right ventricle. This is called “tricuspid insufficiency”. Anoutbreak of tricuspid regurgitation is caused since the tricuspid valvedoes not close completely when it should close because the tricuspidvalve between the right atrium and the right ventricle of the heart isstretched or torn, or the chordae tendinae to fix the valve between themis broken.

As typical treatments for the tricuspid regurgitation according to theconventional art, methods of correcting the disease surgically byopening a patient's chest and cutting the heart, that is, anannuloplasty ring method and a DeVega method, have been widely used.However, in these surgical methods, as a surgical treatment highlyinvasive should be performed, the surgical approach only for thetricuspid valve has not been widely used because the importance of thetricuspid valve is relatively low. That is, when a patient havingtricuspid regurgitation underwent a mitral valve surgery or an importantheart disease surgery of the coronary arteries, etc., the surgicaltreatment of the tricuspid regurgitation as described above was donesimultaneously.

In this regard, there has been a gradually growing global expectation onresearch for treatment for tricuspid regurgitation, which is performedusing a catheter or a simple device, rather than a surgical method ofopening the chest and cutting the heart.

A device for mitral valve cerclage treatment that can be performed witha catheter technique was already proposed by the inventors of thepresent invention (refer to WO2008/060553 published on May 22, 2008).Also, the inventors of the present invention improved a device formitral valve cerclage treatment as described above and proposed a devicefor tricuspid regurgitation surgery (refer to Korean Patent PublicationNo. 10-2015-0144568), for which a PCT international application was alsofiled and published in the WIPO gazette (refer to WO2015/194816).

It can be said that the present invention is an improvement in theinvention of WO 2015/194816 invented by the inventors of the presentinvention.

DISCLOSURE Technical Problem

The present invention has been made to solve the above-mentionedproblems of typical tricuspid regurgitation surgery methods according tothe conventional art and make improvements to the methods. An object ofthe present invention is to provide a device for transcatheter treatmentfor tricuspid regurgitation that can treat the tricuspid regurgitationthrough a simple catheter technique with minimum invasion and increasean effect of the treatment, thus replacing a surgical method of openinga patient's chest and cutting the patient's heart.

Another object of the present invention is to provide a device fortranscatheter treatment for tricuspid regurgitation that can perform thetricuspid regurgitation treatment separately from or together with amitral regurgitation treatment, which was conceived by improving thedevice for mitral valve cerclage surgery invented by the inventors ofthe present invention.

Still another object of the present invention is to provide a device fortranscatheter treatment for tricuspid regurgitation, being customized toa patient, in which a size and a position of a blocking member of thedevice can vary according to the size and the position of the tricuspidvalve of each patient.

Yet still another object of the present invention is to provide a devicefor transcatheter treatment for tricuspid regurgitation, being capableof supporting the tricuspid valve tube stably so as to prevent thetricuspid valve tube from damaging the tricuspid valve.

The present invention is not limited to the objects as described above.Any other objects not mentioned herein could be clearly appreciated by aperson having ordinary knowledge in the art to which the presentinvention pertains, from the description of the invention as describedbelow.

Technical Solution

In order to accomplish the above objects, a device for transcathetertreatment for tricuspid regurgitation according to one exemplaryembodiment of the present invention may include the coronary sinus tubeinserted into the coronary sinus, and the tricuspid valve tubetraversing the tricuspid valve, wherein the coronary sinus tube and thetricuspid valve tube communicate with each other or are adjacent to eachother within a range of predetermined length at an upper side and areseparate from each other at a lower side, a blocking member for blockinga space generated by incomplete closing of the tricuspid valve isprovided at the lower part of the tricuspid valve tube or between thecoronary sinus tube and the tricuspid valve tube, and a stopper forpreventing an end of the tricuspid valve tube from piercing into aninterventricular septum is provided at the lower side of the tricuspidvalve tube.

According to another exemplary embodiment of the present invention, adevice for transcatheter treatment for tricuspid regurgitation mayinclude the coronary sinus tube inserted into the coronary sinus, thetricuspid valve tube traversing the tricuspid valve, and a sheath tubeinto which the tricuspid valve tube is inserted in a predeterminedregion, wherein the sheath tube and the coronary sinus tube are in closecontact with each other, and a blocking member for blocking a space(orifice) generated by incomplete closing of the tricuspid valve isprovided at the lower part of the tricuspid valve tube or between thecoronary sinus tube and the tricuspid valve tube.

According to a still another exemplary embodiment of the presentinvention, a device for transcatheter treatment for tricuspidregurgitation may include the coronary sinus tube inserted into thecoronary sinus, and the tricuspid valve tube traversing the tricuspidvalve, wherein the coronary sinus tube and the tricuspid valve tubecommunicate with each other within a range of predetermined length at anupper side and are separate from each other at a lower side, and ablocking member for blocking a space generated by incomplete closing ofthe tricuspid valve is provided between the coronary sinus tube and thetricuspid valve tube.

According to a yet still another exemplary embodiment of the presentinvention, a device for transcatheter treatment for tricuspidregurgitation may include the coronary sinus tube inserted into thecoronary sinus, the tricuspid valve tube traversing the tricuspid valve,and a blocking member for blocking a space generated by incompleteclosing of the tricuspid valve, the blocking member being provided at alower part of the tricuspid valve tube or between the coronary sinustube and the tricuspid valve tube, wherein a position of the blockingmember is adjusted by adjusting a position of the tricuspid valve tube,so as to be fitted to the space (orifice) generated by the incompleteclosing of the tricuspid valve.

Advantageous Effects

As described above, a device for transcatheter treatment for tricuspidregurgitation according to the present invention is advantageous inenabling simple treatment with minimum invasion, as a catheter treatmenttechnique, enhancing an effect of the treatment and dramaticallyshortening the patient's recovery period, as compared to theconventional surgery methods of opening a patient's chest and cuttingthe patient's heart.

Also, as the device according to the present invention cansimultaneously perform a function to tighten a mitral annulus, thetricuspid regurgitation treatment can be performed separately from orsimultaneously with mitral valve regurgitation treatment. Thus, thepresent invention is advantageous in being capable of undergoing severaltreatments satisfactorily with a single device. Further, as a size and aposition of a blocking member for blocking a space (orifice) made in thetricuspid valve in the systole of the heart can vary, a doctor mayproceed with the treatment according to a size and a position of thespace (orifice) caused by incomplete closing of the tricuspid valvewhich differs from each patient, through an angiography apparatus,providing an advantage in that probability of treatment success can bedrastically increased. In addition, as the tricuspid valve can be stablysupported, the treatment can be performed without causing any damage bythe tricuspid valve tube to the tricuspid valve.

DESCRIPTION OF DRAWINGS

FIG. 1 is a prospective view of a device for transcatheter treatment fortricuspid regurgitation according to one exemplary embodiment of thepresent invention.

FIG. 2 is a view showing a method of varying a length of a cerclage wirein the device for transcatheter treatment for tricuspid regurgitation ofFIG. 1.

FIG. 3 is a view showing a method of moving a position of a stopper inthe device for transcatheter treatment for tricuspid regurgitation ofFIG. 1.

FIG. 4 is a view showing a method of varying the length of the tricuspidvalve tube by means of a holding member in the device for transcathetertreatment for tricuspid regurgitation of FIG. 1, in which (a) shows theholding member before movement and (b) shows the holding member aftermovement.

FIG. 5 is a perspective view of a device for transcatheter treatment fortricuspid regurgitation according to another exemplary embodiment of thepresent invention.

FIG. 6 is a view showing a support wire after a length thereof ischanged in FIG. 5 (after the support wire is pulled up).

FIG. 7 is a perspective view of a device for transcatheter treatment fortricuspid regurgitation according to a still another exemplaryembodiment of the present invention, to explain a method of installing ablocking balloon and changing a size of the blocking balloon.

FIG. 8 is a view showing a shape of a device for transcatheter treatmentfor tricuspid regurgitation after performing treatment using the devicefor transcatheter treatment for tricuspid regurgitation according to thepresent invention is performed.

FIG. 9 is a view showing a principle of treating tricuspid regurgitationusing a device for transcatheter treatment for tricuspid regurgitationaccording to the present invention.

FIG. 10 is a view showing a device for transcatheter treatment fortricuspid regurgitation according to the present invention, blocking aspace (orifice) in the tricuspid valve by passing in and out obliquelywith the tricuspid valve.

FIG. 11 is a view showing a position of a device for transcathetertreatment for tricuspid regurgitation in the heart.

FIG. 12 is a view showing a shape of a device for transcathetertreatment for tricuspid regurgitation after performing treatment usingthe device transcatheter treatment for tricuspid regurgitation isperformed according to a still another exemplary embodiment of thepresent invention.

FIG. 13 is a view illustrating a treatment principle of a device fortranscatheter treatment for tricuspid regurgitation shown in FIG. 12.

FIG. 14 is a view illustrating a treatment principle of tricuspidregurgitation using a device for transcatheter treatment for tricuspidregurgitation according to a yet still another exemplary embodiment ofthe present invention.

DESCRIPTION OF THE SYMBOLS

10: Cerclage wire

12: Arch part

12 a: Arch-shaped protection part

12 b: Coating part

20: Coronary sinus tube (CS tube)

30: Tricuspid valve tub (TV tube)

32: Holding member

40: Sheath tube

50: Stopper

52: Tube for moving stopper

60: Blocking member

61: Blocking balloon

62: Blocking membrane

64: Support wire

65: Tube for support wire

66: Tube for balloon

67: Balloon control hub

Best Mode

Advantages and features of the present invention, and methods to achievethem shall be apparent with reference to exemplary embodiments of thepresent invention hereinafter described in details together with theaccompanying drawings. The embodiments of the present invention may bemodified in various forms, and the scope of the present invention shouldnot be construed as being limited to the following embodiments. Theembodiments of the present invention are just provided for a completedescription, thereby fully informing those skilled in the art of thecategory of the invention. Accordingly, the present invention will bedefined on the basis of the category of the claims.

Specific embodiments to realize the present invention will be describedin detail with reference to the drawings attached hereto. Without regardto the drawings, the same reference numbers refer to the same elements,and “and/or” covers any and all combinations of the elements mentionedherein, including a combination of respective elements or a combinationof one element with two or more elements.

Terms to describe a variety of elements are described, but the elementsare not limited to the terms used herein. The elements are merely usedto distinguish one element from another. In this regard, a firstcomponent described herein may be a second component within thetechnical concept of the present invention.

The terms used herein are terms used to explain exemplary embodiments ofthe present invention, rather than to limit the present invention. Also,a singular form may cover a plural form if it is specially mentionedotherwise. Further, “comprises” and/or “comprising” used herein do notexclude existence or addition of one or more other component than thecomponent(s) mentioned.

Without any other definitions, all the terms used herein (includingtechnical terms and scientific terms) may be used to carry the meaningsthat could be appreciated commonly by those of ordinary knowledge in theart to which the present invention pertains. Also, some terms defined indictionaries usually used will not be construed ideally or excessivelyunless they are explicitly particularly defined herein.

Hereinafter, exemplary embodiments of the present invention will bedescribed in details with respect to the accompanying drawings.

FIG. 1 is a prospective view of a device for transcatheter treatment fortricuspid regurgitation according to one exemplary embodiment of thepresent invention.

Referring to FIG. 1, the device for transcatheter treatment fortricuspid regurgitation of the present invention fundamentally includesa coronary sinus tube 20, a tricuspid valve tube 30, and a blockingmember 60. The coronary sinus tube 20 constitutes a portion insertedinto the coronary sinus of the heart, the tricuspid valve tube 30constitutes a portion traversing (intersecting, crossing) the tricuspidvalve in and out to reach the interventricular septum. The insides ofthe coronary sinus tube 20 and the tricuspid valve tube 30 are hollow soas to allow a cerclage wire 10 to be inserted thereinto. The coronarysinus tube 20 and the tricuspid valve tube 30 communicate with eachother, or are adjacent to each other within a range of predeterminedlength at an upper side and are separate from each other at a lowerside. The coronary sinus tube 20 and the tricuspid valve tube 30 may beformed of rubber materials, synthetic materials such as soft plastic,etc., or metal materials such as a coil spring, etc. Accordingly, thecoronary sinus tube 20 and the tricuspid valve tube 30 are soft andhighly ductile, having excellent recovery together with flexibility toallow the coronary sinus tube 20 and the tricuspid valve tube 30 to moveaccording to heart beats. Also, any material having excellentdeliverability in cerclage treatment may be used.

The cerclage wire (cerclage suture) 10 is named in a sense that thecoronary sinus (CS), the interventricular septum, and the tricuspidvalve (TV) are interconnected, like making a loop. As shown in thedrawings, the cerclage wire refers to a thread (wire) for connecting thecoronary sinus (CS), the interventricular septum, and the tricuspidvalve (TV) into one, like making a loop. As materials of the cerclagewire, synthetic materials such as nylon, etc. or metal (stainless steel,metals coated with nylon, etc.) wires may be used. The cerclage wire maybe a single wire, or in a form such that a number of thin wires aretwisted. The thickness of the cerclage wire may be about 0.5 mm, and thediameter of the tube may be about 2 mm, but they are not necessarilylimited thereto.

An arch part 12 is formed on one side of the cerclage wire 10. In mostpatients (about 80% to 90%), the coronary artery is located beneath thecoronary sinus, and the cerclage wire passes through the coronary sinus.In cerclage treatment, if the coronary artery is located beneath thecoronary sinus, considerable external pressure is applied by thecerclage wire to the coronary artery. To prevent the external pressure,an arch part 12 is formed thereon. The arch part 12 functions to protectthe coronary artery. In the arch part 12 according to the presentinvention, an arch-shaped protection part 12 a is inserted into thecerclage wire 10, and an integral arch part whose form is fixed by acoating part 12 b is used. Polyurethane, polyolefin, silicon,e-polytetrafluoroethylene (e-PTFE), PTFE, etc. for medical purposes areused for the coating part 12 b.

A blocking member 60 constitutes a portion to block a space (orifice)generated by incomplete closing of the tricuspid valve and is located ata lower part of the tricuspid valve tube, or between the coronary sinustube and the tricuspid valve tube. Tricuspid regurgitation is a diseasethat the blood flows backward because the tricuspid valve does not closecompletely in the systole of the heart. A space (orifice) generatedbecause of incomplete closing of the tricuspid valve in the systole ofthe heart is blocked by the blocking member 60 of the present invention.As the blocking member 50, a blocking balloon 61 or a blocking membrane62, etc. may be used. The blocking membrane 62 is shown in FIG. 1. Theblocking membrane 62 is made of materials that are suitable for humanbody and are ductile but not easily torn. Polyurethane, polyolefin,silicon, e-polytetrafluoroethylene (e-PTFE), PTFE, etc. for medicalpurposes are used for the blocking membrane 62.

In order to hold a shape of the blocking membrane 62, a support wire 62is provided in the tricuspid valve tube 30. FIG. 1 shows that both endsof the support wire 62 are fixed at the tricuspid valve tube 30, towhich is not necessarily limited. It is possible that both ends or oneend of the support wire 62 may not be fixed at the tricuspid valve. Thesupport wire 64 may be made of synthetic materials that have apredetermined hardness or metal wires. The thickness thereof may beabout 0.5 mm, but not necessarily limited thereto. The support wire maybe fixed at the blocking membrane, but the support membrane may beformed doubly, and the support membrane may be configured to insert thesupport wire thereinto. In this regard, the support wire may also beconfigured to change a length thereof (refer to the descriptionassociated with FIGS. 5 and 6).

A stopper 50 is formed at a lower side of the tricuspid valve tube 30 inorder to prevent an end of the tricuspid valve tube 30 from piercinginto the interventricular septum. The stopper 50 may be fixed at an endof the tricuspid valve tube 30. However, preferably the stopper 50 maybe formed on a lower end of a tube 52 for moving the stopper, and thetube 52 for moving the stopper is structured to be inserted into thetricuspid valve tube 30, as shown in the drawings. In this structure,the stopper moves along the cerclage wire according to movement of thetube for moving the stopper. As this movement causes the tricuspid valvetube to be kept afloat rather than to be in close contact with theperiphery of the tricuspid valve, it is possible to prevent damage bythe tricuspid valve tube to the tricuspid valve. This configuration willbe described in detail referring to FIG. 3.

A sheath tube 40 constitutes a portion into which the upper side of thetricuspid valve tube 30 is inserted. A holding member 32 is held at anupper end of the tricuspid valve tube 30. As the tricuspid valve tubemoves vertically using the holding member 32, the blocking member 60formed at the tricuspid valve tube 30 can be moved. This configurationwill be described in more detail referring to FIG. 4. Rubber materials,synthetic materials including soft plastic materials such as nylon thatis biologically suitable, or metal materials such as a coil spring maybe used for the tube. An exemplary embodiment that only the tricuspidvalve tube is inserted into the sheath tube is shown in the drawings.However, in some cases, the coronary sinus tube may also be insertedinto a separate sheath tube, and an exemplary embodiment that thecoronary sinus tube and the tricuspid valve tube are simultaneouslyinserted into their respective sheath tubes is also available.

FIG. 2 is a view showing a method of varying a length of a cerclage wirein the device for transcatheter treatment for tricuspid regurgitation ofFIG. 1.

Referring to FIG. 2, the cerclage wire 10 is inserted into the coronarysinus tube 20 and the tricuspid valve tube 30, which are interconnectedinto one, like making one loop. If one side or both sides of thecerclage wire 10 are vertically moved at the upper side (that is, pulledor pushed), the loop formed by the cerclage wire 10 becomes larger orsmaller, as shown in the drawings. According to this, proper tension canbe maintained according to the size and the shape of a patient's heart,and the cerclage wire 10 may be squeezed so as to firmly hold a heartvalve annulus. That is, the wire functions to squeeze a mitral annulus.

FIG. 3 is a view showing a method of moving a position of a stopper inthe device for transcatheter treatment for tricuspid regurgitation ofFIG. 1.

Referring to FIG. 3, the stopper 50 is fixed at the tube 52 for movingthe stopper, which is structured to be inserted into the tricuspid valvetube 30. Here, if the tube 52 for moving the stopper is pushed or pulledat the upper part, the tube 52 for moving the stopper moves along thetricuspid valve tube 30, and the stopper 50 formed on the lower end ofthe tube 52 for moving stopper moves along the cerclage wire.Accordingly, a lower end of the tricuspid valve tube (a portion at whichthe tricuspid valve tube and the coronary sinus tube are separated fromthe stopper) forms a large or small curved line.

Movement of the stopper makes a portion of the tricuspid valve tubecurved (in a reverse form), so as to be stably supported. As the stopperis located at a right ventricular outflow tract (RVOT) portion of theheart, the curved shape is held from the stopper to the portion at whichthe tricuspid valve tube and the coronary valve tube are separated,being kept slightly afloat. According to this, the tricuspid valve tubeis floated over the tricuspid valve rather than to be in close contactwith the periphery of the tricuspid valve, serving to prevent damage bythe cerclage wire or the tricuspid valve tube to the tricuspid valve andfunctioning to less restrict movement of the valves and cusps. That is,movement of the stopper enables the stopper to stably support thetricuspid valve tube.

FIG. 4 is a view showing a method of varying the length of the tricuspidvalve tube by means of a holding member in the device for transcathetertreatment for tricuspid regurgitation of FIG. 1, in which (a) shows theholding member before movement and (b) shows the holding member aftermovement.

Referring to FIG. 4, the upper side of the tricuspid valve tube 30 isinserted into the sheath tube, and the sheath tube 40 and the coronarysinus tube 20 come into close contact with each other, allowing thecoronary sinus tube 20 and the tricuspid valve tube 20 to be adjacent toeach other within a predetermined region. A holding member 32 that canmove the tricuspid valve tube 30 vertically along the sheath tube 40 isfixedly formed at the upper side of the tricuspid valve tube 30.According to vertical movement of the holding member 32, the tricuspidvalve tube 30 moves vertically, enabling a position of the blockingmember 50 formed in the tricuspid valve tube to be adjusted.Accordingly, the blocking member 60 can be adapted to the space(orifice) generated by incomplete closing of the tricuspid valve tube inthe systole of the heart.

In other words, as the size and position of the blocking member whichblocks the space (orifice) generated by incomplete closing of thetricuspid valve tube in the systole of the heart can vary, a doctor canproceed with treatment according to a size and a position of the space(orifice) caused by incomplete closing of the tricuspid valve whichdiffers for each patient, through an angiography apparatus. Accordingly,probability of success in treatment can be drastically increased.

FIG. 5 is a perspective view of a device for transcatheter treatment fortricuspid regurgitation according to another exemplary embodiment of thepresent invention, and FIG. 6 is a view showing a support wire after alength thereof is changed in FIG. 5 (after the support wire is pulledup).

Referring to FIGS. 5 and 6, one side of the blocking membrane 62 isfixed at the tricuspid valve tube and supported by the support wire 64.The blocking membrane 62 is made of two or more layers, and the upperside of the support wire 64 is inserted into a tube 65 for support wirecoupled to the tricuspid valve tube 30, and the lower side thereof isinserted movably between the blocking membranes. A lower end of thesupport wire 64 is fixed at a lower end of the tricuspid valve tube 30.

A space formed in the blocking membrane 62 by the support wire may bechanged according to vertical movement of the support wire at an upperside. That is, according to the vertical movement of the support wire,the support wire at the lower part may be stretched or shortened,thereby causing the space made by the tricuspid valve tube and thesupport wire to be increased or decreased. According to this, the spacecreated by the tricuspid valve tube and the support wire may be adjustedadaptively to the size of the space generated by incomplete closing ofthe tricuspid valve.

Naturally, a holding member as shown in the drawings may be formed at atube for moving stopper, a support wire, and a cerclage wire,respectively, for vertical movement of the tube for moving stopper,movement of the support wire, and movement of the cerclage wire,although they are not shown in the drawings.

FIG. 7 is a perspective view of the device for transcatheter treatmentfor tricuspid regurgitation according to a still another exemplaryembodiment of the present invention, to explain a method of installing ablocking balloon 61 and changing a size of the blocking balloon 61.

Referring to FIG. 7, a blocking balloon 61 is fixed at the tricuspidvalve tube 30, the blocking balloon 61 communicates with a tube 66 forballoon with maintaining airtightness therebetween, and the other end ofthe tube 67 for balloon is coupled to a balloon control hub 67. Theballoon control hub 67 corresponds to a blower to supply air or oxygen.As the size of the blocking balloon 61 is changed depending upon theamount of air or oxygen supplied by the balloon control hub 67, the sizeof the blocking balloon can be adjusted adaptively to the size of thespace generated by incomplete closing of the tricuspid valve tube in thesystole of the heart.

FIG. 8 is a view showing a shape of a device for transcatheter treatmentfor tricuspid regurgitation after performing treatment using the devicefor transcatheter treatment for tricuspid regurgitation according to thepresent invention is performed, FIG. 9 is a view showing a principle oftreating tricuspid regurgitation using a device for transcathetertreatment for tricuspid regurgitation according to the presentinvention, FIG. 10 is a view showing a device for transcathetertreatment for tricuspid regurgitation according to the presentinvention, blocking a space (orifice) in the tricuspid valve by passingin and out obliquely with the tricuspid valve, and FIG. 11 is a viewshowing a position of a device for transcatheter treatment for tricuspidregurgitation in the heart.

Referring to FIGS. 8 to 11, a condition that the blood flows backwardfrom the right ventricle (RV) to the right atrium (RA) (that is, bloodregurgitation) occurs in the tricuspid regurgitation patient because thetricuspid valve tube does not completely close, although the tricuspidvalve must completely close in the systole of the heart. The device fortranscatheter treatment for tricuspid regurgitation according to thepresent invention employs a principle of blocking a space generated byincomplete closing of the tricuspid valve with a blocking memberthereof.

The tricuspid valve tube and the blocking membrane traverse (intersect,cross) the tricuspid valve in and out, to reach the coronary sinus (CS)and the RVOT septum. That is, the tricuspid valve tube and the blockingmembrane are obliquely in parallel, traversing the tricuspid valve. Dueto this structure, the blood of the right atrium (RA) is smoothlydelivered to the right ventricle (RV) in the relaxation of the heart,and the blood of the right ventricle does not flow backward to the rightatrium but flows to the pulmonary artery in the systole of the heart.

The device for transcatheter treatment for tricuspid regurgitationaccording to the present invention is fundamentally an improvement in adevice for a mitral valve cerclage treatment, thus being able toaccomplish treatment for tricuspid regurgitation together with treatmentof the mitral valve regurgitation under a treatment procedure. That is,tricuspid regurgitation is mostly due to secondary or functionaltricuspid regurgitation such as dysfunction of the left ventricle anddysfunction of the mitral valve, and the device for transcathetertreatment for tricuspid regurgitation according to the present inventionresults from modification in the device for a mitral valve cerclagetreatment. Accordingly, the device for transcatheter treatment fortricuspid regurgitation according to the present invention can also bevery effectively and efficiently used in tricuspid regurgitationtreatment together with the mitral valve cerclage treatment.

FIG. 12 is a view showing a shape of a device for transcathetertreatment for tricuspid regurgitation after performing treatment using adevice for transcatheter treatment for tricuspid regurgitation accordingto a still another exemplary embodiment of the present invention, andFIG. 13 is a view illustrating a treatment principle of device fortranscatheter treatment for tricuspid regurgitation shown in FIG. 12.

Referring to FIGS. 12 and 13, the coronary sinus tube and the tricuspidvalve tube communicate with each other as a single tube within apredetermined length at the upper part, and they are separate from eachother at the lower part. And, the blocking member for blocking the spacegenerated by incomplete closing of the tricuspid valve is formed betweenthe coronary sinus tube and the tricuspid valve tube. It is shown thatthe blocking member 60 takes a form of the blocking membrane 62, but itis possible that the blocking member 60 may also be applied to theblocking balloon.

FIG. 14 is a view illustrating a treatment principle of tricuspidregurgitation using a device for transcatheter treatment for tricuspidregurgitation according to a yet still another exemplary embodiment ofthe present invention.

Referring to FIG. 14, the blocking member includes a support wirecoupled to the tricuspid valve tube, and a blocking membrane coupled tothe support wire. The support wire takes a form of a loop, and theblocking membrane is a membrane taking a form of funnel and havingflexibility. The blocking membrane is located at the right ventricle, inthe lower part of which a large orifice is formed by blood pressure inthe relaxation of the heart, allowing the blood to flow smoothly.Conversely, the blocking member is contracted because of the bloodpressure in the contraction of the heart due to a property of themembrane having flexibility, forming a small orifice at the lower part,thereby blocking blood regurgitation. Accordingly, the space generatedby incomplete closing of the tricuspid valve can be efficiently blocked.

Although the present invention has been described with reference toexemplary embodiments shown in the drawings, it will be understood bythose of ordinary skill in the art that the exemplary embodiments havebeen described for illustrative purposes, and various changes andmodifications may be made without departing from the spirit and scope ofthe present invention as defined by the appended claims. Accordingly, itshould be appreciated that the technical embodiments of the presentinvention described above are for illustrative purposes and they shouldnot be construed in a limited manner.

1. A device for transcatheter treatment for tricuspid regurgitation, thedevice comprising: the coronary sinus tube inserted into the coronarysinus; and the tricuspid valve tube traversing the tricuspid valve,wherein the coronary sinus tube and the tricuspid valve tube communicatewith each other or are adjacent to each other within a range ofpredetermined length at an upper side and are separate from each otherat a lower side, a blocking member for blocking a space generated byincomplete closing of the tricuspid valve is provided at the lower partof the tricuspid valve tube or between the coronary sinus tube and thetricuspid valve tube, and a stopper for preventing an end of thetricuspid valve tube from piercing into the interventricular septum isprovided at the lower side of the tricuspid valve tube.
 2. The devicefor transcatheter treatment for tricuspid regurgitation of claim 1,wherein a movable tube for moving the stopper is inserted into thetricuspid valve tube, and the stopper is provided at a lower end of themovable tube for moving the stopper, and is moved along a cerclage wireaccording to movement of the movable tube for moving the stopper.
 3. Thedevice for transcatheter treatment for tricuspid regurgitation of claim1, wherein an upper side of the tricuspid valve tube is inserted into asheath tube, wherein the sheath tube and the coronary sinus tube are inclose contact with each other, allowing the coronary sinus tube and thetricuspid valve tube to be adjacent to each other within thepredetermined region.
 4. The device for transcatheter treatment fortricuspid regurgitation of claim 3, wherein a holding member is providedat a top of the tricuspid valve tube, the holding member being capableof moving the tricuspid valve tube vertically along the sheath tube, anda position of the blocking member is adjusted by moving the tricuspidvalve tube according to vertical movement of the holding member, therebyallowing the blocking member to be fitted to the space (orifice)generated by incomplete closing of the tricuspid valve.
 5. The devicefor transcatheter treatment for tricuspid regurgitation of claim 1,wherein the blocking member is a blocking balloon.
 6. The device fortranscatheter treatment for tricuspid regurgitation of claim 1, whereinthe blocking member is a blocking membrane.
 7. The device fortranscatheter treatment for tricuspid regurgitation of claim 6, whereinthe blocking membrane has one side fixed at the tricuspid valve tube andis supported by a support wire.
 8. The device for transcathetertreatment for tricuspid regurgitation of claim 7, wherein opposite endsof the support wire are fixed at the tricuspid valve tube.
 9. The devicefor transcatheter treatment for tricuspid regurgitation of claim 7,wherein the blocking membrane is formed of two or more layers, andwherein an upper side of the support wire is inserted into a tube forthe support wire coupled to the tricuspid valve tube, a lower side ofthe support wire is inserted movably between the blocking membranes, anda lower end of the support wire is fixed at a lower end of the tricuspidvalve tube.
 10. The device for transcatheter treatment for tricuspidregurgitation of claim 1, wherein the blocking member includes a supportwire coupled to the tricuspid valve tube and a blocking membrane coupledto the support wire.
 11. The device for transcatheter treatment fortricuspid regurgitation of claim 10, wherein the blocking membrane is aflexible membrane having a form of funnel.
 12. A device fortranscatheter treatment for tricuspid regurgitation, the devicecomprising: the coronary sinus tube inserted into the coronary sinus;the tricuspid valve tube traversing the tricuspid valve; and a sheathtube into which the tricuspid valve tube is inserted within apredetermined region, wherein the sheath tube and the coronary sinustube are in close contact with each other, and a blocking member forblocking a space (orifice) generated by incomplete closing of thetricuspid valve is provided at the lower part of the tricuspid valvetube or between the coronary sinus tube and the tricuspid valve tube.13. The device for transcatheter treatment for tricuspid regurgitationof claim 12, wherein a holding member is provided at a top of thetricuspid valve tube, the holding member being capable of moving thetricuspid valve tube vertically along the sheath tube, and a position ofthe blocking member is adjusted by moving the tricuspid valve tubeaccording to vertical movement of the holding member, thereby allowingthe blocking member to be fitted to the space (orifice) generated byincomplete closing of the tricuspid valve.
 14. The device fortranscatheter treatment for tricuspid regurgitation of claim 12, whereina stopper for preventing an end of the tricuspid valve tube frompiercing into the interventricular septum is provided at a lower side ofthe tricuspid valve tube.
 15. The device for transcatheter treatment fortricuspid regurgitation of claim 14, wherein a movable tube for movingthe stopper is inserted into the tricuspid valve tube, and the stopperis provided at a lower end of the movable tube for moving the stopperand is moved along a cerclage wire according to movement of the movabletube for moving the stopper.
 16. The device for transcatheter treatmentfor tricuspid regurgitation of claim 12, wherein the blocking member isa blocking balloon.
 17. The device for transcatheter treatment fortricuspid regurgitation of claim 12, wherein the blocking member is ablocking membrane.
 18. The device for transcatheter treatment fortricuspid regurgitation of claim 17, wherein the blocking membrane hasone side fixed at the tricuspid valve tube and is supported by a supportwire fixed at the tricuspid valve tube.
 19. The device for transcathetertreatment for tricuspid regurgitation of claim 17, wherein the blockingmembrane is formed of two or more layers, and wherein an upper side ofthe support wire is inserted into a tube for the support wire coupledwith the tricuspid valve tube and a lower side of the support wire isinserted movably between the blocking membranes, and a lower end of thesupport wire is fixed at a lower end of the tricuspid valve tube. 20.The device for transcatheter treatment for tricuspid regurgitation ofclaim 12, wherein the blocking member includes a support wire coupled tothe tricuspid valve tube and a blocking membrane coupled to the supportwire.
 21. A device for transcatheter treatment for tricuspidregurgitation, the device comprising: the coronary sinus tube insertedinto the coronary sinus; and the tricuspid valve tube traversing thetricuspid valve, wherein the coronary sinus tube and the tricuspid valvetube communicate with each other within a range of predetermined lengthat an upper side and are separate from each other at a lower side, and ablocking member for blocking a space generated by incomplete closing ofthe tricuspid valve is provided between the coronary sinus tube and thetricuspid valve tube.
 22. A device for transcatheter treatment fortricuspid regurgitation, comprising: the coronary sinus tube insertedinto the coronary sinus; the tricuspid valve tube traversing thetricuspid valve; and a blocking member for blocking a space generated byincomplete closing of the tricuspid valve, the blocking member beingprovided at a lower part of the tricuspid valve tube or between thecoronary sinus tube and the tricuspid valve tube, wherein a position ofthe blocking member is adjusted by adjusting a position of the tricuspidvalve tube, so as to be fitted to the space (orifice) generated by theincomplete closing of the tricuspid valve.
 23. The device fortranscatheter treatment for tricuspid regurgitation of claim 22, whereinthe blocking member is a blocking membrane or a blocking balloon, and isobliquely aligned over the tricuspid valve such that the blocking memberis in parallel with the tricuspid valve.
 24. The device fortranscatheter treatment for tricuspid regurgitation of claim 22, furthercomprising: a stopper for preventing an end of the tricuspid valve tubefrom piercing into an interventricular septum, the stopper beingprovided at a lower side of the tricuspid valve tube; and a tube formoving the stopper being movably inserted into the tricuspid valve tube,at a lower end of which the stopper is provided, wherein the stopper ismoved along a cerclage wire according to movement of the tube for movingstopper.
 25. The device for transcatheter treatment for tricuspidregurgitation of claim 22, wherein the upper side of the tricuspid valvetube is inserted into a sheath tube, and a holding member is provided ata top of the tricuspid valve tube, the holding member being capable ofmoving the tricuspid valve tube vertically along the sheath tube,wherein a position of the blocking member is adjusted by moving thetricuspid valve tube according to vertical movement of the holdingmember, thereby allowing the blocking member to be fitted to the space(orifice) generated by incomplete closing of the tricuspid valve.